Intern, Technology Transfer

1 week ago


Bandar Baru Enstek, Malaysia Novugen Pharma Sdn Bhd Full time

**About us**

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

**About the role**
- To support TT personnel, R&D and plant teams during trial batch execution to ensure robust and scalable products are met. Facilitate manufacturing, validation of new products and processes
- Generate key documents including the Technology Transfer Checklist, Feasibility Study Plans, Technology Transfer Report, Technology Transfer Certificate, New Production Introduction Form, compilation of scale up and exhibit batch data.
- To support preparation, review and approval of TT related documents (Protocols & Reports) as well as regulatory submission by co-ordination with other cross-functional teams which include R&D and plant teams
- To support Trial, Pilot / Scale-up, Hold Time, and Exhibit batches as well as monitoring data of the product at respective manufacturing sites
- Collect and organize process optimization and scale-up data generated during both the optimization and exhibit batches. Ensure this data is prepared for cross-functional review and analysis.
- Compile and document all technical aspects related to Technology Transfer, as well as process improvement data from completed batches.
- Adherence to Novugen’s site standards, in particular Quality, Ethical, Safety, Health, Environment and Information security
- Ensures adherence to cGMP requirements, Guidelines, and SOPs.
- Any other ad hoc tasks assigned by the management

**About You**
- Bachelor’s degree holder in (Pharmacy, Pharmacology, Chemistry, Biotechnology, Biochemistry, Business studies or any relevant fields)
- Has 1 Internship position for duration of min 3 month(s) and above.
- Strong analytical skills with proficiency in Excel and data analysis. (i.e., mathematical formula, VLOOKUP, SUMIF, etc.) is advantageous
- Versatile and resilient, ability to stay positive in high-pressure and ambiguous environments and work towards delivering results
- Proficient communication skills and problem-solving skills
- Enthusiastic, proactive, and eager to learn
- Ability to work collaboratively in a cross-functional team environment
- Willing to work at Bandar Enstek, Negeri Sembilan

**Job Type**: Internship
Contract length: 6 months

Pay: RM1,000.00 per month

Schedule:

- Monday to Friday

Work Location: In person


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